MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRIO ST; SURGICAL MESH

Catalog Number 5950020

Device Problems Defective Device (2588); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Cellulitis (1768); Fistula (1862); Neuropathy (1983); Hernia (2240); Disability (2371); Swelling/ Edema (4577)

Event Date 06/14/2018

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the bard/davol ventrio st device may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges the patient underwent surgery in 2017 with partial removal of the bard/davol ventrio st and has allegedly "suffered pain, neuropathy, fistula, scarring, and intestinal blockage".No medical records have been provided; however, fistula formation is identified in the adverse reaction section of the instructions-for-use as a possible complication.The actual date of injury is unknown, reported as "2017"; therefore, we are using (b)(6) 2017 as date of event.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.Note: the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned.

Event Description

The following was alleged by the patient's attorney: on (b)(6) 2015: the patient was implanted with a bard/davol ventrio st mesh, referece number (b)(4), lot huzh0899, for the repair of an incarcerated incisional hernia.It is alleged that no less than a year had passed before the patient started experiencing pain radiating from his abdomen and neuropathy.As reported, the patient's physicians elected for a repair surgery of the hernia and hernia mesh.In 2017, the patient underwent surgery and removed part of the mesh.It is alleged that the patient has suffered pain, neuropathy, fistula, scarring, and intestinal blockage and will continue to suffer physical pain from his hernia surgery.

Manufacturer Narrative

Currently, it is unknown to what extent the bard/davol ventrio st device may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges the patient underwent surgery in 2017 with partial removal of the bard/davol ventrio st and has allegedly "suffered pain, neuropathy, fistula, scarring, and intestinal blockage".No medical records have been provided; however, fistula formation is identified in the adverse reaction section of the instructions-for-use as a possible complication.The actual date of injury is unknown, reported as "2017"; therefore, we are using (b)(6) 2017 as date of event.Based on the limited information provided at this time, no conclusions can be made.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the date of event, date of explant and manufacturing date.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 2 years 5 months post implant of ventrio st, patient was diagnosed with hernia recurrence, edema and cellulitis thereby underwent repair.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Updated fields: a2, b4, b5, b6, b7, e3, g1, g3, g6, h2, h6, h10, h11.Corrected fields: b3(date of event), d.6b (date of explant), h4(manufacturing date).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : not returned.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2015: the patient was implanted with a bard/davol ventrio st mesh, referece number (b)(4) , lot huzh0899, for the repair of an incarcerated incisional hernia.It is alleged that no less than a year had passed before the patient started experiencing pain radiating from his abdomen and neuropathy.As reported, the patient's physicians elected for a repair surgery of the hernia and hernia mesh.In 2017, the patient underwent surgery and removed part of the mesh.It is alleged that the patient has suffered pain, neuropathy, fistula, scarring, and intestinal blockage and will continue to suffer physical pain from his hernia surgery.Addendum per additional information provided: (b)(6) 2015 - patient was diagnosed with incarcerated ventral incisional hernia just around umbilicus thereby underwent laparoscopic repair with the implant of ventrio st mesh (device #1).Per operative notes, ¿there was omentum which incarcerated up in the incisional hernia was reduced.A ventrio-st mesh (device #1) was placed intraperitoneally and pulled up against the anterior abdominal wall and tacked circumferentially.¿.(b)(6) 2018 - patient was diagnosed with recurrent epigastric/ventral incisional hernia thereby underwent robotic repair with the implant of ventralight st mesh (device #2).(note: there was no operative notes provided for this procedure).Attorney alleges that the patient had fistulae, pain, neuropathy, scarring and intestinal blockage.

• Brand Name: VENTRIO ST
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 7611577
• MDR Text Key: 111401237
• Report Number: 1213643-2018-02018
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031519
• UDI-Public: (01)00801741031519
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Catalogue Number: 5950020
• Device Lot Number: HUZH0899
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 06/12/2024
• Supplement Dates FDA Received: 06/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female